Mizolastine in the treatment of seasonal allergic rhinoconjunctivitis: a European clinical experience with 5408 patients managed in daily practice (PANEOS SAR Study)

Background: Mizolastine, a potent H-1 antihistamine with additional antiall ergic properties, is marketed for the treatment of allergic rhinoconjunctiv itis and urticaria. The objective was to investigate the safety and effecti veness of mizolastine under conditions of daily practice in patients with s easonal allergic rhinoconjunctivitis (SAR). Methods: In an open multicenter study, mizolastine 10 mg daily was administ ered for 14 days during the pollen season. Nasal and ocular symptoms, time to onset of symptom relief, and effect of the drug on diurnal alertness wer e evaluated. Safety was evaluated on the basis of self-reported adverse eve nts (AE). Results: A total of 5408 patients (36 +/- 14 years of age, females = 57%) w ith a history of SAR for 8 +/- 9 years were treated for a mean of 17.1 +/- 5.0 days. SAR symptoms improved in 93% and decreased by at least 50% in 86% of patients; 78% reported improvement after the first drug intake and 51% from the first hour. Sixty-nine percent considered mizolastine more effecti ve than other antihistamines taken previously. The incidence of AE was low (3.8%). Conclusions: The high responder rate, the rapid onset of action, and the lo w incidence of AE observed in this large multicenter study confirm the prev iously reported beneficial efficacy and safety of mizolastine in the manage ment of SAR.